Kornimate/medical-research-clean huggingface dataset:
siri checklist: an integrated hospital model to optimize hiv prevention in persons who inject drugs

Conditions: HIV Infections; Opioid-Related Disorders; Pre-Exposure Prophylaxis (PrEP)

Summary: the purpose of this study is to develop and test a serious injection-related injections (siri) checklist aimed at increasing evidence-based treatment for rural people who use drugs (pwud) including innovative, long-acting injectable agents. the central hypothesis is that hospital-based care models can successfully engage rural and southern (pwud) in effective addiction treatment and infection prevention. the activities in this study will be foundational to ending the hiv epidemic in rural states.

aim 1: we will conduct a prospective study of 60 pwud hospitalized at uab. using a standardized survey, we will elicit hiv risk behaviors, substance use, and hiv-related stigma. we will use the 14-item behavioral risk assessment for infectious diseases (braid) scale, which queries drug use and sexual behaviors while using drugs. we will also collect clinical and patient reported data related to infections (bacterial, viral), prep use, hcv treatment, and medication for opioid use disorder (moud). we will query perception of hiv risk, prep awareness, and interest. surveys will be completed electronically in private hospital rooms to reduce social desirability bias. aim 2: we will conduct surveys with 60 pwud hospitalized at uab to evaluate attitudes and preferences toward opioid use disorder (oud) treatment and hiv prevention, including long-acting injectable formulations. we will explore interest and preferences related to hospital initiation of each medication. each session will include open-ended questions on barriers, such as stigma, and opportunities for increasing evidence-based care including hiv prevention and addiction treatment. aim 3: the siri checklist will build on the existing standard of care for siri, addiction medicine and id consultation, by adding a standardized reminder to offer moud, prep, and arrange appropriate community-based care with both addiction and id providers. siri checklist will be inspired by the icare checklist, developed for endocarditis in pwid, but will be applicable for all pwud and will incorporate hiv prevention education and linkage to care, including hepatitis c (hcv) treatment. the checklist will be integrated into the provider's documentation using a smartphrase text for ease of use and standardization. of the 60 participants we will randomize them to siri checklist (15), siri checklist plus enhanced peer recovery coach (15), enhanced peer recovery coach (15), or standard of care (15).

Eligibility criteria:
inclusion criteria: * we will include 60 pwud with serious injection related infections (siri) who are hiv negative, ≥ 18 years old, have opioid use disorder (oud) and receiving care at uab hospital exclusion criteria: * we will exclude those unable to provide informed consent due to acute illness or intoxication, those who don't have oud, and those who are hiv positive in order to inform hiv prevention interventions.
fludarabine and rituximab for the treatment of marginal zone non-hodgkin's lymphoma

Conditions: Lymphoma, Non-Hodgkin; MALT Lymphoma

Summary: the purpose of this study is to determine the effectiveness of six cycles of concurrent fludarabine and rituximab in patients with mucosa-associated lymphoid tissue (malt) lymphoma, marginal zone lymphoma (mzl) or cd5-, cd10-, cd20+ low-grade b cell lymphomas.

objectives: primary - to estimate the objective response rate. secondary * to assess the safety. * to describe the progression-free survival at one year. * to examine the association between clonal cytogenetic abnormalities identified by fish, and the objective response rate as well as the progression-free survival at one year. target enrollment was 30 eligible patients. an 80% objective response rate at 1 month restaging after 6 cycles was considered as evidence of activity in this patient population while 60% was not considered activity. if at least 22 patients achieved objective response the treatment would be considered promising. with 30 eligible patients, the probability of observing this was 0.87 assuming a true rate of 80% and 0.09 assuming a true rate of 60%.

Eligibility criteria:
inclusion criteria: * histologically confirmed, newly diagnosed or relapsed malt, marginal zone lymphoma, or low-grade b cell lymphoproliferative disorder which is cd5-, cd10- and cd20+ * pathology must be reviewed at brigham \& women's hospital, massachusetts general hospital, or the university of rochester james p. wilmot cancer center prior to enrollment * documentation of cd20+ status * must not be a candidate for local radiotherapy with curative intent * if gastric malt, not a candidate for antibiotic therapy with curative intent * patients with leukemic phase marginal zone lymphoma are eligible if their absolute lymphocyte count is \>10,000 / µl * prior treatment with rituximab is permitted, if rituximab induced an objective response which persisted for at least 6 months * prior radiotherapy is acceptable * measurable disease * anc: \> 1000/mm3 * platelets: \> 100,000/mm3 * hemoglobin: \> 7 gm/dl * adequate renal function as indicated by serum creatinine \<= 2 mg/dl. * adequate liver function, as indicated by serum total bilirubin \<= 2 mg/dl. * ast or alt \<3x upper limit of normal unless related to primary disease. * men and women of reproductive potential must agree to use an acceptable method of birth control during study treatment and for six months after completion of study treatment. * who performance status \</= 2 * subject has provided written informed consent. exclusion criteria: * patients with waldenstrom's macroglobulinemia or lymphoplasmacytic lymphoma are excluded * history of hiv * active infection * known cns disease * pregnant (a negative serum pregnancy test should be performed for all women of childbearing potential within 7 days of treatment) or currently lactating women * prior treatment within the last three weeks * prior fludarabine * positive direct antiglobulin test

Keywords: fludarabine rituximab marginal zone lymphoma malt lymphoma
research of predictive factors to immune thrombopenic purpura

Conditions: Purpura Thrombopenic

Summary: it is about a multicentric study prospective of more than patients' 60 years with a thrombopenia isolated of less than 100 g/l blood platelet without cause found to estimate so certain examinations realized in the diagnosis (medullary cytogenetics, dosage of the tpo, the anti-platelet antibodies, isotopic lifetime of platelet) are in favour of the diagnosis of pti.

it is about a multicentric study prospective of more than patients' 60 years with a thrombopenia isolated of less than 100 g/l blood platelet without cause found to estimate so certain examinations realized in the diagnosis (medullary cytogenetics, dosage of the tpo, the anti-platelet antibodies, isotopic lifetime of platelet) are in favour of the diagnosis of pti. the principal endpoint is to evaluate if the medullary cytogenetics is the predictive factor of the diagnosis of pti in front of a thrombopenia isolated in elderly. the secondary endpoints are : * to identify at the time of the diagnosis, the factors and/or predictive markers correlated in the final diagnosis of pti or smd * to study the respective frequency of the pti and the smd in front of a thrombopenia seemingly isolated of the subject of more than 60 years. 200 patients will be included. 160 patients should be assessable at the end of study by considering the excluded patients, the dead and the lost sight.they will be followed every 4 months, during two years. in every visit, will be realized a clinical examination, a blood film, a haemogram. if the haemogram is abnormal, a bone marrow biopsy is realized. the patient who presents a myelodysplastic syndrome is excluded.

Eligibility criteria:
inclusion criteria: * rate of platelet \< 100 g/l for less than 12 months , * age = ou \> 60 years, * haemoglobin \> ou = 12 g / dl at the woman, \> ou = 13 g/dl at the man, * polymorphonuclear neutrophil \> ou = 1.7 g/l, * monocytes \< ou= 1 g/l, * lymphocytes \< ou = à 4 g/l, * vgm \< 100 fl, blood film normal, * informed consent, * expectation of life \> 6 months exclusion criteria: * hepatomegaly, * splenomegaly, * hepatic abnormality, * blood coagulation abnormality, * antecedent of auto-immune disease, * drug thrombopenia, * hiv, vhb or vhc positive, * antecedent of malicious tumor in the 5 years before inclusion

Keywords: purpura thrombopenic medullary cytogenetics myelodysplasic syndrome bone marrow biopsy
holter versus zio patch electrocardiographic monitoring in children

Conditions: Arrhythmias, Cardiac; Heart Block

Summary: this prospective study aims to compare the diagnostic yield, or ability to detect an arrhythmia, of the traditional holter monitor versus the novel zio patch monitor in pediatric patients referred for ambulatory electrocardiographic (ecg) monitoring. children will wear both devices simultaneously for 48 hours and the incidence of clinically significant arrhythmias will be compared.

patients under age 22 years at children's hospital of new york (chony) who are referred for ambulatory ecg monitoring will be consented and enrolled prospectively to have the holter monitor and the zio patch placed simultaneously in the pediatric cardiology clinic. patients will be instructed to wear both devices for 48 hours. demographic data will be collected, including date of birth, age, gender, weight, height, chest circumference, body surface area, indication for ambulatory ecg monitoring, prior congenital heart disease, prior cardiac surgery, and prior holter or zio patch use. a patient satisfaction survey will be given to the patient and parent/guardian after completion of the study to compare the comfort, interference with daily activities, adverse events (such as skin irritation or if either device fell off), and preference for each device. holter monitors will be returned to the clinic along with the patient satisfaction survey, and the zio patch will be mailed back to manufacturer headquarters and the report will be returned to the investigators.

Eligibility criteria:
inclusion criteria: * any patient under age 22 years who has been referred for ambulatory ecg monitoring at children's hospital of new york. exclusion criteria: * any known skin allergy or sensitivity to adhesive material.

Keywords: ambulatory electrocardiography holter monitor zio patch monitor pediatrics
ketone dose and cerebral blood flow study

Conditions: Cerebrovascular Function; Cognition

Summary: ketone bodies are produced by the liver during periods of food scarcity or severe carbohydrate restriction. blood ketones are an alternative fuel source used by the brain, heart, and skeletal muscle during periods of fasting. further, ketones bodies act as a signalling molecule that have pleiotropic effects that upregulate cellular stress-resistance pathways throughout the body. oral supplements containing exogenous ketones have recently become available and represent a novel tool for increasing plasma ketone bodies without the need for dietary restriction. early evidence suggests that oral ketone supplements may enhance cerebral blood flow and improve cognition. however, the dose-dependent effects of a single ketone supplement on cerebral blood flow and cognition in young adults is currently unknown. the purpose of this study is to characterize the effects of ingesting a high versus low dose of an oral ketone monoester on cerebral blood flow, circulating blood markers, and cognition in young adults. as an exploratory aim, this study will investigate how oxygen uptake kinetics during submaximal exercise are impacted 2 hours after ingestion of a ketone supplement. recent findings indicate that ketone supplementation may impair exercise performance due to the physiological stress (i.e., ph disturbances) imposed by an acute ketone dose. delaying exercise onset by 2 hours after ingestion of a ketone supplement may enhance oxygen kinetics in a dose-dependent manner.


Eligibility criteria:
inclusion criteria: - between the ages of 18 and 35 exclusion criteria: * presence of obesity (body mass index \> 30 kg/m\^2) * presence of known cardiovascular disease * presence of type 2 diabetes * history of cardiovascular events requiring hospitalization (i.e., heart attack) * history of concussion(s) with persistent symptoms * currently following a ketogenic diet and/or taking ketone body supplements

Keywords: cerebral blood flow cognition beta-hydroxybutyrate (β-ohb)
comparison of low and high phytosterol diets with respect to cholesterol metabolism

Conditions: Hypercholesterolemia; Coronary Heart Disease

Summary: the objective of this study is to compare cholesterol absorption and metabolism after feeding diets naturally low or high in phytosterols. all meals will be prepared in a metabolic kitchen and analyzed for phytosterols. in a randomized crossover design a group of up to 25 healthy subjects will consume diets containing either 100 mg/day or 600 mg/day phytosterols for 4 weeks. at the end of each dietary period percent cholesterol absorption, fecal cholesterol excretion and ldl cholesterol level will be measured. the hypothesis is that ldl cholesterol and cholesterol excretion will be improved on the high phytosterol diet even though macronutrient composition, mineral intake and fiber consumption are similar.


Eligibility criteria:
inclusion criteria: * male or female of any race or ethnicity between 18 to 80 years of age, inclusive; * body mass index between 20-35 kg/m2; * ldl-cholesterol between 100-189 mg/dl based on the average of duplicate screening measures. if the two ldl-c levels differ by more than 30 mg/dl, a third test will be scheduled with all three results averaged; * free of chronic disease; * willing to eat only the foods that are provided by the center during the diet periods; * willing to consume no more than 1 alcoholic drink per day. * willing to abstain from the consumption of alcohol for 48-hours prior to blood draw days; * willing to drink no more than 5 cups of caffeine-containing beverages a day. exclusion criteria: * age \ 80 years; * based on duplicate screening laboratory values: 1) ldl-c \> or = 190 mg/dl; 2) tg \> or = 250 mg/dl; 3) blood pressure \> or = 160 mm hg systolic or 95 mm hg diastolic; * documented presence of atherosclerotic disease; * diabetes mellitus; * renal, hepatic, endocrine, gastrointestinal, hematological or other systemic disease; * body mass index \> 35; * for women, pregnancy, breast feeding or postpartum \< 6 months; * for women, peri-menopausal; * history of drug or alcohol abuse; * history of depression or mental illness requiring treatment or medication within the last 6 months; * multiple food allergies or significant food preferences or restrictions that would interfere with diet adherence; * chronic use of over-the-counter medication which would interfere with study endpoints including laxatives and antacids; * lifestyle or schedule incompatible with the study protocol; * planned continued use of dietary supplements through the study trial; * taking any lipid-lowering, or other medications known to affect blood cholesterol

Keywords: phytosterols cholesterol excretion cholesterol absorption diet mass spectrometry deuterium
safety and feasibility of ire for srms

Conditions: Kidney Cancer

Summary: irreversible electroporation (ire) is an emerging technique delivering electrical pulses to ablate tissue, with the theoretical advantage to overcome the main shortcomings of conventional thermal ablation. recent short-term research showed that ire for the ablation of renal masses is a safe and feasible treatment option. in an ablate and resect design, histopathological analysis 4 weeks after radical nephrectomy demonstrated that ire targeted renal tumors were completely covered by ablation zone. in order to develop a validated long-term ire follow-up study, it is essential to obtain clinical confirmation of the efficacy of this novel technology. additionally, follow-up after ire ablation obliges verification of a suitable imaging modality. the objectives of this study are the clinical efficacy and safety of ire ablation of renal masses and to evaluate the use of cross-sectional imaging modalities in the follow-up after ire in renal tumours. this is a prospective, human, in-vivo study among 20 patients presenting with solid enhancing srm on cross sectional imaging suspect for renal cell carcinoma (rcc). preoperatively, imaging is required through magnetic resonance imaging (mri), contrast-enhanced ultrasound (ceus) and contrast-enhanced computed tomography (ct). furthermore, serum creatinine levels and vas scores are obtained. a biopsy of the srm will be performed in preoperative setting. ire ablation will be performed using ct-guidance and ablation success will be measured directly after the ablation through contrast-enhanced ct. device related adverse events (ae) will be registered using the common terminology criteria for adverse events (ctcae) version 4.0 guideline. one week post ablation only ceus and mri will be performed to limit exposure to ionizing radiation. at 3 months, 6 months and 12 months post ablation ceus, mri and ct will be performed. additionally, at these time points serum creatinine levels and vas scores will be obtained, and quality of life will be assessed through sf-36 questionnaires. residual and recurrent disease will be assessed through tissue enhancement on cross sectional imaging.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * solid, enhancing mass on cross sectional imaging * signed informed consent * candidate for focal ablative therapy exclusion criteria: * irreversible bleeding disorders * inability/unwillingness to interrupt anticoagulation therapy * previous cryoablation, rfa or partial nephrectomy in affected kidney * anaesthesia surgical assignment (asa), category ≤ iv * icd / pacemaker
a study evaluating implementation strategies for the delivery of apretude for black cis-and transgender women in united states ehe territories

Conditions: HIV Infections

Summary: the purpose of the study is to evaluate the appropriateness, adoption, feasibility, fidelity, and acceptability of implementation strategies and cabotegravir (cab) pre-exposure prophylaxis (prep). the study objectives are also to identify barriers and facilitators to implementation. the first of two participant types in the study are the patient study participants (psps) will refer to individuals who are enrolled in the study and who will receive commercially available cab prep via prescription from the prep provider. the second are staff study participants (ssps) who are site staff involved in the administrative and clinical aspects of offering and administering prep to psps at the clinical site.


Eligibility criteria:
inclusion criteria: * participant must be ≥18 years of age, at the time of signing the informed consent. * hiv negative at screening. type of hiv-1 test is per standard of care. * no prior history of receiving oral cab or cab la injections. * prep provider deems cab prep use to be appropriate per the applicable cab prep prescribing information prior to enrollment in the study. * female at birth or self-identified transgender female. * self-identified as african american/black * capable of giving signed informed consent exclusion criteria: * hiv indeterminate or positive test result during screening. * a participant of concurrent interventional clinical or implementation science study at any time during the study. * cis-gender or transgender male

Keywords: cabotegravir long acting injectables implementation science hiv prep hiv disparities ending the epidemic engaging black women on apretude by optimizing novel implementation strategies (eboni)
early diabetes resolution after weight loss surgery

Conditions: Obesity; Diabetes

Summary: the primary objective is to compare inflammatory, hormonal, and metabolic changes in the very short term after various bariatric surgical procedures (roux-en y gastric bypass, vertical sleeve gastrectomy, and adjustable gastric banding)and other abdominal surgeries, as well as to compare these changes to diet-induced changes in the same population.


Eligibility criteria:
inclusion criteria for surgery groups: * bmi of 30 kg/m2 or higher * ages 18-65 * history of impaired glucose tolerance or t2dm inclusion criteria for normal weight group: * bmi of 30 kg/m2 or lower * ages 18-65 exclusion criteria: * development of an intercurrent infection * prior gastric, duodenal, proximal jejunal surgery or pancreas resection * current use of thiazolidinediones * current use of dipeptidyl peptidase-iv inhibitors (e.g., sitagliptin) or glucagon-like peptide-1 analogs (e.g., exenatide) * any condition felt by the pi or co-investigators to interfere with ability to complete the study

Keywords: obesity diabetes bariatric surgery
pelvic endometriosis: correlation of us and mri with laparoscopic findings

Conditions: Endometriosis

Summary: endometriosis is classically defined as the presence of endometrial glands and stroma outside the uterine cavity and its musculature. the definition of deep endometriosis is based on anatomic assumptions that may prove erroneous. in fact, the term '' deep endometriosis '' should be reserved for lesions in the retroperitoneal tissue. for practical purposes, several reports included in the so-called deep endometriosis the infiltrative forms that involve vital structures such as the bowel, ureters, and bladder, as well as forms such as many rectovaginal lesions. for the term ''deep'' to apply, there should be ectopic endometrial tissue penetrating the peritoneum more than 5 mm in depth. the ectopic endometrium responds to hormonal stimulation with various degrees of cyclic hemorrhage which result in suggestive symptoms and appearances. a common symptom is infertility. pelvic pain is a frequent complaint among patients with endometriosis. such pain generally manifests as secondary dysmenorrhea, worsening primary dysmenorrhea, dyspareunia, or even noncyclic lower abdominal pain and backaches. the pain may be site-specific when endometriosis is found in unusual locations outside the pelvis. diagnosis physical examination and laparoscopic exploration may not allow diagnosis or prediction of the extension of deep pelvic endometriosis, especially in pelvic retroperitoneal sites. transvaginal sonography is recommended for diagnosis of endometriomas and endometriosis of the bladder but its value for assessment of superficial peritoneal lesions, ovarian foci, and deep pelvic endometriosis is uncertain. mr imaging is now commonly used for diagnosis of endometriosis and provides a tremendous advantage over other methods of investigation, owing to the possibility of making a complete survey of the anterior and posterior compartments of the pelvis at one time. mri is becoming a mainstay of preoperative diagnosis, in particular for diagnosis deep infiltrating endometriosis.

a prospective study including 30 female patients of reproductive who were previously clinically diagnosed to have endometriotic lesions. these will be sent to our department to identify the extent of the lesions and clarify the exact location for proper treatment. all patients were evaluated with ultrasound and mri. the sensitivity, specificity and diagnostic accuracy for both examination were calculated. transvaginal ultrasound and mri will be done in our radiology department to all patients after signing an informed consent to be enrolled in the study. all our imaging results were finally compared to the laparoscopic results which are our gold standard.

Eligibility criteria:
inclusion criteria: * female patients who have symptoms consistent with endometriosis such as pelvic pain, dysmenorrhea, deep dyspareunia, and infertility exclusion criteria: * the common contraindication to mri, peacemaker, metallic foreign bodies, and claustrophobia